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FDA 510(k)

MOWANA™ Auto Duo

Número K: K261266 · 2026-09-17

RequerentePENTAMASTER MEDIQ SDN BHD
Data da decisão2026-09-17
Código do produtoFMI
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

MOWANA™ Auto Duo is the device name listed in this FDA 510(k) record. The listed applicant is PENTAMASTER MEDIQ SDN BHD. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K261266. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MOWANA™ Auto Duo?

MOWANA™ Auto Duo is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is PENTAMASTER MEDIQ SDN BHD. The 510(k) number is K261266.

When did MOWANA™ Auto Duo receive FDA 510(k) clearance?

MOWANA™ Auto Duo received FDA 510(k) clearance on 2026-09-17, under 510(k) number K261266.

Who is the listed applicant for MOWANA™ Auto Duo?

The FDA 510(k) record lists PENTAMASTER MEDIQ SDN BHD as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOWANA™ Auto Duo?

The FDA product code for MOWANA™ Auto Duo is FMI.

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